- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04919343
Do Video Materials Help Parents to Support Infant Development?
April 12, 2022 updated by: Danielle Matthews, University of Sheffield
A Randomised Controlled Trial to Evaluate the Efficacy of BBC Education's Tiny Happy People Content in Supporting Infant Language Development.
The aim of this project is to assess whether video materials from the BBC Tiny Happy People (THP) campaign are effective in terms of improving the language skills of socioeconomically disadvantaged children before they start school.
This project will also look at how useable the service is for parents in terms of acceptability, effects on self-efficacy and implementation of advice.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The current study will evaluate BBC Education's Tiny Happy People initiative (https://www.bbc.co.uk/tiny-happy-people) which seeks to reduce the impact of social and economic disadvantage on children's language skills before they arrive at primary school.
BBC Education have created videos for parents and other caregivers with information about child development, tips and activities as well as other content of interest.
The aim of the evaluation is to find out how parents feel about the materials and whether the videos promote a) caregiver confidence at 12, 18 and 24 months, b) caregiver-infant interaction at 12, 18 and 24 months and c) child language at 18 and 24 months.
The primary outcome is expressive vocabulary size at 17-18 months.
Families with 4- to 9-month-old infants who would like to take part will be randomly allocated either to a language support group or a physical health active control group and sent short, age-appropriate advice videos by text message three times a month until their children are 18 months old (with follow up videos for children until the age of 2 years where possible given study time limits).
Study Type
Interventional
Enrollment (Actual)
435
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Yorkshire
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Sheffield, South Yorkshire, United Kingdom, S1 2LT
- University of Sheffield
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months to 9 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Families must:
- be raising their child as a monolingual English speaker (at least 80% of the language they hear in the home is English)
- have a postcode in deciles 1-5 of the Office of National Statistics Index of Multiple Deprivation
- have access to the internet and a device to watch videos (via smart phone)
Infants must:
- be full term
- have a healthy birthweight
Exclusion Criteria:
Neither caregivers nor infants must have any significant known physical, mental or learning disability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BBC Tiny Happy People intervention
Parents will be sent links each month directing them to BBC Tiny Happy People content via SMS text message using the secure service FireText.
This content will be aimed at supporting language development.
Parents will be asked to watch the video content and incorporate it into their parenting practices.
The intervention will start when infants are aged 4-9 months and conclude when they are 18 months with a follow up to 24 months where time permits.
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This intervention involves regular texting of BBC Education Tiny Happy People videos to parents
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Active Comparator: Physical health control
Similar to the experimental condition, parents will be sent links each month via SMS text message using FireText.
These links will direct them to publicly available web content with tips to promote the healthy development of their baby, focusing on things such as healthy eating, physical activities, and dental care.
The intervention will start when infants are aged 4-9 months and conclude when they are 18 months with a follow up to 24 months where time permits
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This intervention involves regular texting of publicly available videos about supporting infant physical and dental health to parents
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
18 month expressive vocabulary
Time Frame: 2 months. Parents will complete the report within 2 months of the infant turning 18 months old.
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Infant expressive vocabulary, assessed using the communicative development inventory (CDI) at 18 months
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2 months. Parents will complete the report within 2 months of the infant turning 18 months old.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregiver responsive behaviour at 12, 18 and 24 months
Time Frame: Measures will be collected within 2 months of the child turning 12, 18 and 24 months
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Parents willing and able to upload a 5-minute video of a play time with their child will have the option to do so.
A researcher will code the video using the PaRRis rating scale.
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Measures will be collected within 2 months of the child turning 12, 18 and 24 months
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Caregiver self-efficacy at 12, 18 and 24 months
Time Frame: Measures will be collected within 2 months of the child turning 12, 18 and 24 months
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Parents will be sent a self-efficacy questionnaire to complete in the format of a qualtrics survey, via SMS text message at each time point.
Questions will focus on how parents feel about their parenting in general and supporting their child's language development and physical health.
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Measures will be collected within 2 months of the child turning 12, 18 and 24 months
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24 month expressive vocabulary
Time Frame: 3 months. Parents will complete the report within 3 months of the infant turning 24 months old.
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Infant expressive vocabulary, assessed using the communicative development inventory (CDI) at 24 months
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3 months. Parents will complete the report within 3 months of the infant turning 24 months old.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention uptake - number of video links that were clicked on
Time Frame: Clicking on a video link within one month of it being sent
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Parents will be sent regular text messages with links to videos with information about supporting child language or physical health.
We will take % of links clicked as a fidelity measure.
We will check whether parents were more likely to click though to these links in one condition or the other and run a Complier Average Causal Effect analysis.
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Clicking on a video link within one month of it being sent
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Danielle Matthews, PhD, University of Sheffield
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2021
Primary Completion (Anticipated)
November 30, 2022
Study Completion (Anticipated)
May 31, 2023
Study Registration Dates
First Submitted
June 2, 2021
First Submitted That Met QC Criteria
June 2, 2021
First Posted (Actual)
June 9, 2021
Study Record Updates
Last Update Posted (Actual)
April 20, 2022
Last Update Submitted That Met QC Criteria
April 12, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 165718
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymised Individual Participant Data will be archived using the Open Science Framework's repository.
For those participants who give permission, video data will also be archived such that researchers who have signed a confidentiality agreement can access this data.
IPD Sharing Time Frame
Data will be made available at the same time as publication, anticipated within 2 years of study completion.
It will remain available for at least 10 years.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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